Days following the Food and Drug Administration (FDA) update on the status of the jerky treat investigation; the Agency released their long-awaited proposed rule for pet food and animal feed: The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.

While mainstream media has been busy tripping over themselves extolling the virtues of the proposed rule, Poisoned Pets has been busy combing through the 400+ page tome with a fine-tooth flea comb.

Discovered hiding amongst the endless pages of legal babble were critical omissions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the foundation on which our food safety laws rest, were found ignored and those that were cited referenced the law incorrectly.

Exemptions

Exemptions were made for adulterated ingredients, raw materials and ingredients contaminated with pests, undesirable microorganism, or extraneous materials, “if a manufacturer wishes to use such materials in manufacturing food”.

Incredibly, exemptions for hazards that may be intentionally introduced, such as economically motivated adulteration, including by acts of terrorism were exempted. Food and drug allergies were also exempted, along with facilities responsible for raw agriculture commodities and facilities that store packaged animal food were exempted.

The exemptions were couched with language used to justify allowances for adulterated animal food using with absurd arguments such as the following:

Proposed § 507.1(d) …In some facilities, “waste” from human food production, such as by-products that may not be edible for humans, or lack nutritional value for humans, are used or sold for animal food. Many species of animals have different digestive systems and nutritional requirements than humans, thus allowing for this use.

Missing Proposals

Other preventive controls and verification procedures were not proposed at all: vital operations such as product testing, environmental monitoring, supplier approval and verification programs, methods for reviewing and tracking consumer complaints, and the electronic submission of food safety plans.

When rules were proposed, many were neatly divided along the lines of voluntary v. mandatory rules, the gulf between requirements and recommendations being vast in terms of enforcement.

Some proposals had such flimsy rules – they hardly seemed like rules at all:

Proposed § 507.25(b)(1)(iv)…Visual inspection alone could identify certain physical hazards in incoming raw materials and ingredients and prevent certain contaminated ingredients from being added to animal food.

Fluffy Proposals

The bulk of the proposed rule, in general, address superficial rather than substantive issues such as record keeping and hazard analysis plans, while the significant and sweeping proposed changes we hoped for were largely ignored.

As I read the rule, I kept hoping that I was mistaken, that somehow I was misunderstanding their meaning. But throughout the 400+ page tome glaring omissions continually appeared in the proposed rule, making it difficult to ignore that the health of animals did not appear to be their priority.

Industry Gets a Pass

The proposed rule will not prevent adulterated food from continuing to enter commerce. In essence, it appears as if great consideration was given to industry and little consideration was given to protecting the health of animals. The proposed rule gives industry a pass and, it would seem, they will be protected from substantively being required to change the way in which pet food and animal feed is made.

Slaughter of the FD&C Act

The most disgraceful and egregious example in the proposed rule is the Agency’s slaughter of the FD&C Act as it applied to adulterated food.

Further detailing how the proposed rule will legally define an adulterated pet food or animal feed is outlined in the following excerpt (emphasis added):

VIII. Proposed Subpart A–General Provisions

A. Proposed § 507.1–Applicability and Status

FDA is proposing in § 507.1(a) that the criteria and definitions in part 507 apply in determining whether an animal food is adulterated:

(1) Within the meaning of section 402(a)(3) of the FD&C Act in that the animal food has been manufactured under such conditions that it is unfit for food; or

(2) within the meaning of section 402(a)(4) of the FD&C Act in that the animal food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Proposed § 507.1(a) provides a basis for applying the criteria and definitions in proposed part 507 in determining whether, under particular circumstances, an animal food is adulterated under section 402(a)(3) or section 402(a)(4) or in violation of section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264).

Cherry Pickin’

To understand the scope of the critical omissions in the proposed rule of the FD&C Act with regards to adulterated food, I created the following table to best illustrate how the FDA cherry picked the FD&C Act:

Title 21 – FOOD AND DRUGS; CHAPTER 9 – FEDERAL FOOD, DRUG, AND COSMETIC ACT; SUBCHAPTER IV – FOOD; Sec. 342 – Adulterated food

§ 342. Adulterated food A food shall be deemed to be adulterated–	Is it included in the proposed rule for animal food?
(a)(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.	NO
(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or	NO
(B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or	NO
(C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or	NO
(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or	Yes
(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or	Yes
(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or	NO
(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or	NO
(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title	NO

Your opinion matters

The proposed rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, is published in the Federal Register so that the public (that’s you!) can review it and submit comments. We are asking that consumers comment on these proposed rules, because your input and perspective will help shape the proposed rule.

LINKS:

• The Fact Sheet: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Federal Register)
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Regulations.gov, an easier format to read)
• Download and view original printed format

UP NEXT: Stay tuned for Part II: Half-assed proposed new law leaves pets at risk  and Part III…coming soon!